This invention relates to blow/fill/seal packaging machines. More particularly, this invention relates to a protective shroud for a fill station in a blow/fill/seal packaging machine.
Aseptic processing is important for packaging pharmaceutical products. Blow/fill/seal or BFS technology is a convenient manufacturing technique used to produce liquid-filled containers. A typical blow/fill/seal machine is described in U.S. Pat. No. 4,707,966 to Weiler et al. A container is formed, filled, and sealed in a continuous operation in an enclosed environment. Pharmaceutical liquid dosage forms can be aseptically manufactured in this manner provided precautions are taken to maintain an aseptic environment.
The present invention provides a convenient and efficient means for maintaining an enclosed aseptic region around a fill station of a blow/fill/seal packaging machine.
A telescoping fill station shroud in a blow/fill/seal packaging machine surrounds a blowing and filling mandrel and guards against contamination of produced aseptically filled packages. The fill station shroud is particularly advantageous in the production of liquid filled vials.
The telescoping fill station shroud is positioned around and shields a fill station mandrel. The fill station shroud includes telescoping open-ended sleeves and a manifold plate. An open-ended upper sleeve is slidably received over an open-ended lower sleeve, or vice versa, and the manifold plate is mounted over a proximal end portion of the upper sleeve.
When the upper sleeve is slidably received over the lower sleeve, the lower sleeve has an external collar at a distal end portion thereof to which a support arm can be attached.
An access aperture sized to receive a filling mandrel is defined by the manifold plate, as well as at least one curtain gas inlet port which is in flow communication with the upper sleeve. Preferably, a pair of opposed curtain gas inlet ports are defined in the manifold plate.
In the drawings,
For ease of description, the telescoping fill system shroud embodying this invention will be described in its normal (upright) operating position. Terms such as upper, lower, horizontal, etc. will be used with reference to its normal operating position. The device embodying the invention, however, may be fabricated, stored, transported, and sold in an orientation other than the position described herein.
Referring to
If desired, the sleeve positions relative to one another can be reversed. That is, upper sleeve 22 can be sized so as to be slidably received within lower sleeve 20.
Lower sleeve 20 is provided with an optional, external collar 24, attached to shroud support arm 18, which engages distal periphery 26 of upper sleeve 22 during storage or shipping. Proximal periphery 28 of upper sleeve 22 is attached to manifold plate 30 which, in turn, is connected to carrier plate 16. Collar 24 is preferred for the embodiment where the upper sleeve is received slidably over the lower sleeve.
As best seen in
The lower sleeve 20, as well as the upper sleeve 22, preferably have an oblong, i.e., oval or rectangular, transverse cross-section so that more than one mandrel such as mandrel 12 can be positioned within a single telescoping fill station shroud, if desired.
Referring to
An alternate embodiment of the manifold plate is shown in
In operation, a curtain gas such as sterile air or nitrogen is introduced, preferably as laminar flow, into the telescoping fill station shroud via curtain gas inlet ports 48 and 50 under positive pressure, passes downwardly through the shroud, and exits below the shroud, thereby isolating mandrel 12 as well as the parison segment from ambient atmosphere.
The telescoping fill station shroud can be disposable or reusable, as desired. Suitable materials of construction are polypropylene, polyethylene, tetrafluoroethylene, 316 stainless steel, and the like. A reusable shroud must be made of a sterilizable USP Class 6 material.
The foregoing description and drawings are intended as illustrative and are not to be taken as limiting. Variations, modifications, and rearrangements of parts are possible without departing from the spirit and scope of the described embodiments and will readily present themselves to those skilled in the art.
Number | Name | Date | Kind |
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5279670 | Watanabe | Jan 1994 | A |
6171293 | Rowley | Jan 2001 | B1 |
7963830 | Luddy | Jun 2011 | B2 |
9440754 | Colangelo | Sep 2016 | B2 |
20010017021 | Sanfilippo | Aug 2001 | A1 |
20160324998 | Reed | Nov 2016 | A1 |
Number | Date | Country | |
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20190375528 A1 | Dec 2019 | US |